Caregiver Involvement for Underage Alcohol Use

Recruiting at 1 trial location

Overseen By Ashley Vetor, MPH, CCRP

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 6 months

585 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Family Check Up, Teen Intervene - Adolescent Only, Teen Intervene with Caregiver Session for underage alcohol use?

Research on similar family-based interventions, like Smart Choices 4 Teens, shows that involving families can reduce teen drinking and improve communication about alcohol. Additionally, active aftercare programs have been effective in reducing alcohol use relapse in adolescents, suggesting that structured support can be beneficial. ^{1 2 3 4 5}

How does the Teen Intervene - Adolescent Only treatment differ from other treatments for underage alcohol use?

Teen Intervene - Adolescent Only is unique because it focuses solely on the adolescent, without involving parents, which contrasts with many other programs that include parental involvement as a key component to prevent or reduce alcohol use among teens. ^{6 7 8 9 10}

What is the purpose of this trial?

Intervention for mild severity alcohol use among U.S. teens is crucial, as alcohol is the most commonly used substance in this age group, yet few receive the necessary interventions. Primary care, where over 90% of youth regularly visit, is an ideal setting for identifying and addressing mild alcohol use disorder (AUD) through brief interventions like motivational interviewing (MI) and cognitive-behavioral therapy (CBT). However, for teens with mild AUD, a single brief session may not be sufficient, raising questions about the role of caregiver involvement. This study seeks to determine the most effective level of caregiver involvement-no involvement, a single live session, or an online self-paced program-in reducing alcohol use among adolescents with mild AUD in primary care settings. The study also explores the impact of these interventions on other outcomes such as substance use and psychosocial functioning, as well as the factors influencing treatment response. The results will guide the selection and implementation of effective, scalable interventions in primary care to address youth alcohol use disorders.

Research Team

Tamika Zapolski, PhD, HSPP

Principal Investigator

Indiana University

Zachary Adams, PhD, HSPP

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for U.S. teens aged 12-17 who have mild to moderate alcohol use problems, as determined by their primary care provider or clinical assessments. Participants must be fluent in English and are willing to undergo brief interventions aimed at reducing alcohol consumption.

Inclusion Criteria

I am between 12 and 17 years old.

Mild to moderate severity for alcohol use (based on standardized surveys from their primary care provider or clinical indication)

English language fluency

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Teen Intervene brief intervention with varying levels of caregiver involvement

6 months

Multiple sessions over 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Assessments at 3, 6, and 12 months post-intervention

Treatment Details

Interventions

• Family Check Up
• Teen Intervene - Adolescent Only
• Teen Intervene with Caregiver Session

Trial Overview The study tests three approaches: Teen Intervene without caregiver involvement, Teen Intervene with a live session including the caregiver, and Family Check Up which is an online program for caregivers. The goal is to find out which method best reduces teen drinking.

Participant Groups

Group I: Teen Intervene - Online Caregiver Support Tool Experimental Treatment 1 Intervention

Only the youth will participate in the brief intervention, Teen Intervene. The youth will participate in two Teen Intervene sessions. Caregiver(s) will be provided with an online tool (Family Checkup Online) that addresses parenting strategies to support their youth.

Group II: Teen Intervene - Caregiver Involvement Experimental Treatment 1 Intervention

The youth will participate in two Teen Intervene sessions. Additionally, the caregiver(s) will participate in a single, caregiver-only Teen Intervene session.

Group III: Teen Intervene - Adolescent Only Active Control 1 Intervention

Only the youth will participate in the brief intervention, Teen Intervene. The youth will participate in manual-standardized Teen Intervene sessions.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

References

1. Canada pubmed.ncbi.nlm.nih.gov

Evaluation of an Assertive Continuing Care Program for Hispanic Adolescents. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Teenage alcohol use. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Twelve-month follow-up of aftercare for adolescents with alcohol use disorders. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Preventive interventions addressing underage drinking: state of the evidence and steps toward public health impact. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Prevention of alcohol use in older teens: A randomized trial of an online family prevention program. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Parenting factors associated with reduced adolescent alcohol use: a systematic review of longitudinal studies. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

24-month outcomes of an eHealth universal program for students and parents to prevent adolescent alcohol use: A cluster randomized controlled trial in schools. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Parent-based interventions for preventing or reducing adolescent substance use - A systematic literature review. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Diagnosis and treatment of teen drug use. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Adolescent drug and alcohol use. Strategies for assessment, intervention, and prevention. [2019]